Closing date for applications: 30 November 2019
MAC Clinical Research have a vacancy for a full time Senior Clinical Research Associate to be based in the North West of England. MAC is one of the UK's most successful Clinical Development Organisations. We conduct and execute clinical trials in various therapeutic areas. Excellent communication skills and the ability to work within a team are essential.
You must be available to travel at least 70% of the time (within the UK and internationally – including flying) and you should possess a full and valid UK driving licence.
Responsibilities of the role:
Performing site qualification, selection, initiation, monitoring and close-out visits.
Maintaining all documentation relating to study set-up and monitoring activities e.g. monitoring plans, visit reports, study status trackers
Communicating regularly with assigned study sites and the project team
Provide protocol and related study training to allocated sites
Manage study progress by tracking regulatory submissions, site initiation, subject recruitment, CRF completion, and data query resolution.
Assess the quality of site practices, procedures and study data and escalating any quality issues as appropriate
Qualifications and Skills:
A Bachelor’s degree or equivalent in a health care or other scientific discipline
Significant on-site, independent monitoring experience. Preferably, a minimum of 3 years in a CRA role within the Pharmaceutical or CRO Industries.
Excellent oral and written communicative skills. Fluent in oral and written English
Excellent time management skills to organise and prioritise workload.
Ability to lead by example on process development, departmental and project objectives, and overall business strategy and initiatives.
Able to proactively identify risks and issues and be able to devise mitigation and contingency plans and solve problems as they arise.
Encourage other team members to apply the same approach to seek solutions.
Knowledge of drug development process including the relationship between the CRO industry and Pharmaceutical companies.
Knowledge of the regulatory framework that surrounds drug development and the clinical trial process.
Knowledge of clinical trial process; including the interaction between the DM team and clinical operations
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking
25 days annual leave + bank holidays (increasing in increments to 30 days after 6 years service)
Your birthday off work
No weekend work/night shift
MAC Clinical Research invites applications from highly motivated candidates with a desire to achieve their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
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Salary: Competitive + Negotiable £ Apply Now